The following data is part of a premarket notification filed by Lifescan Europe, A Division Of Cilag Gmbh with the FDA for Onetouch Via On-demand Insulin Delivery System.
| Device ID | K163357 |
| 510k Number | K163357 |
| Device Name: | OneTouch Via On-Demand Insulin Delivery System |
| Classification | Pump, Infusion, Insulin Bolus |
| Applicant | LifeScan Europe, A Division Of Cilag GmbH Gubelstrasse 34 Zug, CH Ch-6300 |
| Contact | Kirsten Franco |
| Correspondent | Kirsten Franco LifeScan Inc. 965 Chesterbrook Blvd Wayne, PA 19087 |
| Product Code | OPP |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-30 |
| Decision Date | 2017-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00373108000037 | K163357 | 000 |
| 00373108000020 | K163357 | 000 |
| 00373108000006 | K163357 | 000 |
| 00373108000013 | K163357 | 000 |